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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lithotriptor, extracorporeal shock-wave,urological
Regulation Description Extracorporeal shock wave lithotripter.
Product CodeLNS
Regulation Number 876.5990
Device Class 2


Premarket Reviews
ManufacturerDecision
DORNIER MEDTECH
  SUBSTANTIALLY EQUIVALENT 2
EDAP TECHNOMED
  SUBSTANTIALLY EQUIVALENT 1
HEALTHTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 6
MEDISPEC, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Normal 11
No Known Device Problem 11
Kinked 3
Device Issue 2
Inappropriate shock 1
Total Device Problems 28

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